Posted:1 week ago| Platform:
Work from Office
Full Time
Role & responsibilities Key Responsibilities: Strategic & Policy Development: Define, implement, and continuously improve QA/QC policies, procedures, and standards aligned with global best practices (e.g., ISO, GMP, Six Sigma). Develop strategic quality plans in alignment with organizational objectives. Team Leadership: Lead and manage the QA/QC team, including hiring, training, mentoring, and performance evaluation. Foster a high-performing team culture with a strong focus on accountability, results, and continuous improvement. Quality Management System (QMS): Monitor and improve the organizations QMS to ensure effectiveness and compliance with applicable standards. Lead quality system implementations, upgrades, and documentation control. Audits & Compliance: Plan, coordinate, and execute internal and external audits. Ensure ongoing compliance with regulatory and customer requirements. Develop and track corrective and preventive actions (CAPAs) from audit findings. Customer Feedback & CAPA: Review and analyze customer complaints and feedback. Lead root cause investigations and implement robust CAPA processes to prevent recurrence. Cross-Functional Collaboration: Partner with Production, Engineering, R&D, and Supply Chain teams to integrate quality into all operations. Promote quality best practices across the value chain. Data Analysis & KPI Monitoring: Analyze quality metrics and KPIs to identify trends and areas for improvement. Report on performance against targets, and develop action plans for gaps. Supplier Quality Management: Oversee supplier quality performance and conduct supplier audits. Develop and maintain strong relationships with suppliers to ensure quality standards are met. Training & Culture Building: Lead organization-wide quality training initiatives. Promote a proactive culture of quality, compliance, and continuous improvement. Reporting & Communication: Present quality performance metrics, risk assessments, and improvement strategies to senior leadership. Provide recommendations for strategic quality initiatives. Preferred candidate profile Bachelors or Masters degree in Engineering, Quality Management, or a related field. 8+ years of experience in Quality Assurance/Quality Control, with at least 3 years in a leadership role. Strong knowledge of QMS standards (e.g., ISO 9001, ISO 13485, GMP, Six Sigma). Proven experience with internal/external audits, CAPA, and risk management. Excellent analytical, problem-solving, and decision-making skills. Strong interpersonal and leadership capabilities. Certifications such as Six Sigma (Black Belt), Lead Auditor, or ASQ Certified Quality Manager are a plus.
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